Court ruling on morning-after pill: Scientific integrity in policymaking v. Obama administration politics

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FDA2-620x400A federal judge, overruling Obama administration policy in a decision calling for the government to make the morning-after pill available over the counter for all ages, said the administration’s policy was “politically motivated, scientifically unjustified, and contrary to agency precedent.” This case demonstrates once again that there remain significant questions about the strength and limits of Obama’s commitment to scientific integrity in policymaking in cases when the science is inconvenient for policymaking and political messaging.

The New York Times reported on April 6 (“Judge Orders Morning-After Pill Available for All Ages”):

A federal judge ruled Friday that the government must make the most common morning-after pill available over the counter for all ages, instead of requiring a prescription for girls 16 and younger. In his ruling, he also accused the federal government of “bad faith” in dealing with the requests to make the pill universally available, and said its actions had been politically motivated.

The decision … counteracts an unprecedented move by the Obama administration’s Health and Human Services secretary, Kathleen Sebelius, who in 2011 overruled a recommendation by the Food and Drug Administration to make the pill available for all ages without a prescription.

In a decision in a lawsuit filed by advocates, the judge, Edward R. Korman of Federal District Court, ruled that the government’s refusal to lift restrictions on access to the pill was “arbitrary, capricious, and unreasonable.” …

Scientists, including those at the F.D.A., have been recommending unrestricted access for years, as have major medical groups, including the American Medical Association, the American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics. They contend that the restrictions effectively keep many adolescents and younger teenagers from being able to use a safe drug in a timely way to prevent pregnancy, which carries greater safety risks than the morning-after pill.

In 2011, the F.D.A. commissioner, Dr. Margaret A. Hamburg, issued a statement saying that after rigorous study, it was safe to sell Plan B One-Step over the counter for all ages. But she was overruled by Ms. Sebelius, the Health and Human Services secretary, the first time such a public countermanding had ever occurred. …

In his ruling on Friday, Judge Korman also raised the issue of politics, saying that Ms. Sebelius’s decision was “politically motivated, scientifically unjustified, and contrary to agency precedent.”

I believe Sebelius is very unlikely to have made such a precedent-setting, FDA-science-overriding decision without direction from the White House, or at least a clear alignment with White House political priorities. Obama was able to hide behind Sebelius on a decision that may well have been essentially a re-election campaign attempt to head off Republican criticism and perhaps limit damage with Catholic voters.

Reuters reported on April 5 (“Judge strikes restrictions on ‘morning-after’ pill”):

Representatives of the Department of Health and Human Services were not immediately available to comment on the ruling.

One FDA veteran praised the decision, though.

“This has been a 10-year saga during which the FDA was not allowed to do its role properly, not allowed to make science-based decisions,” said Susan Wood.

Wood resigned from the FDA as assistant commissioner for women’s health in 2005 over its decision not to approve over-the-counter sales of emergency contraception. She is now director of the Jacobs Institute of Women’s Health at George Washington University in Washington.

“This decision gives the FDA the chance to reclaim its ability to make decisions based on science, medicine and evidence,” Wood said, “not politics.”

For concise and solidly-argued views on the problems with the Obama administration’s original Plan B decision, and the potential slippery-slope danger in setting a precedent for allowing politics to overrule an FDA science-based decision, see:

“With the Plan B decision, the Obama administration broke its promise” (Washington Post op-ed, December 2011,
 by Susan F. Wood)

“Free the F.D.A.” (New York Times op-ed, December 13, 2011, by Daniel Carpenter)

“Politics and the Morning-After Pill” (New York Times editorial, December 7, 2011)

Earlier posts:

What to do when the White House sets science aside?

“Smog Rules” — Obama, scientific integrity, and environmental policy (article in Index on Censorship)

This entry was posted in Obama Administration, Science-Policy Interaction, Scientific Integrity. Bookmark the permalink.

2 Responses to Court ruling on morning-after pill: Scientific integrity in policymaking v. Obama administration politics

  1. Fred Fighter says:

    What does this have to do with Climate?

    • Rick - Climate Science Watch says:

      Fair question. Two points:
      First, we are concerned with the question of government integrity in making the connection between scientific findings and policymaking — granted that is a complex matter. We have posted multiple times on such issues of scientific integrity as they pertain to the Obama administration, even in some cases that are not specifically about climate. We have noted that, while this administration is not as prone to misrepresenting or suppressing scientific assessments as was its predecessor, the administration does sometimes appear to set science aside when science says things that are seen as politically inconvenient. We wrote about this in the posts:

      What to do when the White House sets science aside?
      http://www.climatesciencewatch.org/2012/01/08/what-to-do-when-the-white-house-sets-science-aside/

      “Smog Rules” — Obama, scientific integrity, and environmental policy (article in Index on Censorship)
      http://www.climatesciencewatch.org/2011/12/05/smog-rules/

      We posted a four-part series on the White House scientific integrity guidelines:
      http://www.climatesciencewatch.org/2011/01/12/scientific-integrity-guidelines-part1/

      Second, Climate Science Watch is a program of the Government Accountability Project, the nation’s leading whistleblower counsel and advocacy organization, and was established following my own experience as a whistleblower. That experience, and my experience working with GAP, have sensitized me to the significance of whistleblowing as a significant mode of public service under the appropriate circumstances. FDA whistleblower Susan Wood, who resigned to protest the Bush administration’s Plan B decisionmaking, has also been critical of the Obama policy that was the subject of this recent court ruling:

      “With the Plan B decision, the Obama administration broke its promise”
      http://www.washingtonpost.com/opinions/with-the-plan-b-decision-the-obama-administration-broke-its-promise/2011/12/08/gIQAznYqiO_story.html

      So, we have found this case to be illustrative of some of the concerns related to what drives Climate Science Watch, and we took the liberty of posting on it. We do that with other cases from time to time, as well as covering some of the developments in whistleblower-related legislation and administration policy. This category of posts is archived on this website at: http://www.climatesciencewatch.org/category/whistleblowers/.

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